Purpose
To compare the 1‐year outcomes of treat‐and‐extend (TAE) and every‐other‐month (2M) regimens with intravitreal aflibercept in Japanese wet age‐related macular degeneration (AMD) patients.
Methods
Prospective, multicenter, randomized clinical trial. The primary outcome measure was the proportion of eyes in which the best‐corrected visual acuity (BCVA) was maintained at week 52 [with a loss of <0.3 logarithm of minimum angular of resolution (logMAR) units]. The secondary outcome measures were the mean change from baseline in the central retinal thickness (CRT) and the number of injections.
Results
Forty‐one patients were enrolled. The mean changes in the BCVA from baseline in the TAE and 2M were −0.32 ± 0.27 and −0.26 ± 0.30 logMAR units (p = 0.46). The TAE group was noninferior to the 2M group in BCVA maintenance. The mean CRT changes from baseline in the TAE and 2M were −161 ± 133 and −157 ± 90 μm (p = 0.73). The mean number of injections in the TAE and 2M were 7.5 ± 1.2 (range, 7–12) and 8.0 ± 0.0 (p < 0.0001).
Conclusion
Treat‐and‐extend (TAE) regimen with aflibercept improved the BCVA and CRT to the same extent as 2M regimen, with a reduced number of injections.